The Last Taboo: Patenting Human Beings
Expert Opinion on Therapeutic Patents, Vol. 14, No. 7, pp. 1061-1074, July 2004
Posted: 14 Oct 2004
This article considers the efforts of the Australian Law Reform Commission to clarify the meaning of section 18(2) of the Australian Patents Act 1990 (Cth): 'Human beings and the biological processes for their generation are not patentable inventions.' It provides a critique of the proposals of the Commission with respect to patent law and stem cell research. The Commission has recommended that IP Australia should develop examination guidelines to explain how the criteria for patentability apply to inventions involving stem cell technologies. It has advised the Australian Government that the practice code of the United Kingdom Patent Office (UKPO) would be a good model for such guidelines, with its distinction between totipotent and pluripotent stem cells. Arguably, though, there is a need to codify this proposal in a legislative directive, and not merely in examination guidelines. The Commission has been reluctant to take account of the ethical considerations with respect to patent law and stem cell research. There could be greater scope for such considerations, by the use of expert advisory boards, opposition proceedings and the requirement of informed consent. The Commission has put forward a number of general and specific recommendations to enhance access to patented stem cell technologies. It recommends the development of a research exemption, and the modernisation of compulsory licensing and crown use provisions. It also explores the establishment of a stem cell bank and the promulgation of guidelines by funding agencies. Such proposals to promote greater public access to stem cell research are to be welcomed.
Keywords: Patent law, stem cell research, human cloning, patent administration, examination guidelines, law reform, research exemption, compulsory licensing, crown use, stem cell banks, funding guidelines
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